United Health Products Submits Response Letter to FDA

Rhea-AI Summary

United Health Products (OTCPK: UEEC) has provided an update on its FDA Premarket Approval (PMA) application process. The company submitted a Submission Issue Request to the FDA on August 15, responding to questions and outlining its approach to address deficiencies identified in the FDA's June 18 'Deficiencies Letter'. UHP has requested a video conference with the FDA PMA application review team, expected to take place in early September. The FDA's 180-day review period, currently at about 90 days, remains paused during this engagement. CEO Brian Thom expressed anticipation for an interactive discussion with the FDA to clarify necessary actions for a final determination on the PMA application. However, there is no guarantee of approval for the company's PMA application.

Positive

• Company proactively responding to FDA's Deficiencies Letter
• Requested video conference with FDA review team for interactive engagement
• Approximately half of the FDA's 180-day review period still remains

Negative

• FDA review process paused due to identified deficiencies
• No assurance of PMA application approval
• Potential delays in product approval and market entry

MT. LAUREL, NJ, Aug. 19, 2024 (GLOBE NEWSWIRE) -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval (PMA) application process.  

Following the company’s March 21 submission of its PMA application and the FDA’s June 18 “Deficiencies Letter” to the company listing certain questions and comments on various elements of the application, on August 15, UHP submitted a Submission Issue Request to the FDA responding to certain questions and detailing its approach to addressing certain identified deficiencies. 

The company has requested video conference with the FDA PMA application review team to discuss its responses and proposed solutions to the deficiencies. UHP anticipates the meeting to take place in early September. 

UHP’s Chief Executive, Brian Thom, commented: “We look forward to an interactive engagement with the FDA to gain clarity on what actions and information are needed in order to make a final determination on the merits of our PMA application.”

The FDA’s 180-day application review period, of which approximately 90 days have elapsed, will remain paused while the company engages further with the FDA and addresses any remaining deficiencies. 

There can be no assurance that the company’s PMA application will be approved.

About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market. 

For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.

The company can also be reached by phone or text message at 475.755.1005.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.

FAQ

What is the current status of United Health Products' FDA PMA application?

United Health Products (UEEC) has submitted a Submission Issue Request to the FDA on August 15, 2024, responding to questions and outlining its approach to address deficiencies identified in the FDA's June 18 'Deficiencies Letter'. The company has requested a video conference with the FDA review team, expected in early September.

How long has the FDA been reviewing United Health Products' PMA application?

The FDA's 180-day review period for United Health Products' PMA application began on March 21, 2024. Approximately 90 days have elapsed, but the review is currently paused while the company addresses the FDA's identified deficiencies.

What are the next steps for United Health Products (UEEC) in the FDA approval process?

United Health Products (UEEC) is awaiting a video conference with the FDA PMA application review team, expected in early September 2024. The company will engage with the FDA to clarify necessary actions and information needed for a final determination on their PMA application.

Is there a guarantee that United Health Products' PMA application will be approved by the FDA?

No, there is no guarantee that United Health Products' (UEEC) PMA application will be approved by the FDA. The company explicitly stated in their press release that there can be no assurance of approval for their PMA application.